In this role, you have the opportunity to
Act as a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
You are responsible for
- Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
- Act as a Project Manager with internal CAPA owners to manage all aspects of CAPA activities which include gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
- Train and mentor CAPA owners in all required elements and best practices of CAPA, including containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks.
- Work effectively with all levels of... management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
- Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
- Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency Represent CAPAs during audits and CAPA Review Board meetings.
- Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree in an engineering or scientific-related field or equivalent technical experience
- 5+ years work experience in quality functions, experience with CAPA is required; experience in Medical/automotive related industry is preferred.
- Able to understand and analyze complex problems, including software and hardware design issues.
- Demonstrated deep knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations,
- Work knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
- Demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels.
- Strong Project Management skills, including ability to project manage all CAPA activities.
- Ability to analyze data and apply statistical techniques.
- Ability to assess risk as it pertains to the CAPA